Table 1.

Anticipated annual enrollment of multiple myeloma patients to BMT CTN protocol 0102, required sample size, and total years of accrual for a biologic assignment trial compared to a randomized trial which can only randomize patients with a matched-sibling donor. Figures are given for various proportions of patients with an HLA-matched sibling donor. The sample sizes required correspond to 90% power to detect a difference between the auto-allo arm and the auto-auto arm with respect to three year progression-free survival (PFS) rates of 60% (auto-allo) vs. 45% (auto-auto). A two-sided type I error rate of 5% is used with no correction for interim analyses.

% with HLA-Matched Sibling Donor	Trial Design	Annual enrollment	Sample Size required	Years of Accrual
20%	Biological Assignment (all patients)	254	720	2.8
	Randomized trial (matched sibling donors only)	51	462	9.1
25%	Biological Assignment (all patients)	254	615	2.4
	Randomized trial (matched sibling donors only)	63	462	7.3
30%	Biological Assignment (all patients)	254	550	2.2
	Randomized trial (matched sibling donors only)	76	462	6.1